Chronic InsomniaNCT07770945
Effects of Connective Tissue Massage in Patients With Chronic Insomnia
A study testing Connective Tissue Massage and Sleep Hygiene Education in people with Chronic Insomnia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial will investigate the effects of connective tissue massage on insomnia severity, objective and subjective sleep outcomes, and stress- and autonomic-related biomarkers in adults with chronic insomnia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Connective Tissue Massage and Sleep Hygiene Education
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years, of either sex.
- Diagnosis of chronic insomnia disorder according to the International -Classification of Sleep Disorders, Third Edition, Turkish version (ICSD-3-TR), established by a neurologist.
- Difficulty initiating or maintaining sleep occurring at least three nights per week for at least three months, consistent with ICSD-3-TR diagnostic criteria.
- No use of pharmacological agents for insomnia during the previous four weeks, including benzodiazepines, non-benzodiazepine hypnotics, melatonin and melatonin receptor agonists, sedating antidepressants, and anxiolytics.
- Insomnia Severity Index score of ≥15, indicating moderate to severe insomnia. Ability to read and write.
- Standardized Mini-Mental State Examination score of ≥24, indicating adequate cognitive status.
- Willingness to participate in the study and provision of written informed consent.
Who cannot join
- History of shift work during the previous month or lifestyle changes that may disrupt circadian rhythm.
- Presence of obstructive sleep apnea syndrome, circadian rhythm sleep-wake disorders, or other primary sleep disorders.
- History of any neurological diagnosis, such as epilepsy or Parkinson's disease, or psychiatric diagnosis, such as depression or bipolar disorder.
- Presence of an open wound, infection, dermatitis, or other dermatological condition impairing skin integrity in the area where connective tissue massage will be applied.
- Regular use of medications that may affect sleep, including antidepressants, beta-blockers, or corticosteroids.
- Initiation of any pharmacological treatment for insomnia, including sleep medications or sedatives, during the four-week study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sultan 2.Abdulhamid Khan Educational and Research Hospital
Istanbul, 34668
GULBALA GULOREN, PhD, +90 553 613 25 07, nakipgulbala@gmail.com
About this study
Official title: The Effects of Connective Tissue Massage in Patients With Chronic Insomnia: A Randomized Controlled Trial
This randomized controlled trial will investigate the effects of connective tissue massage on insomnia severity, objective and subjective sleep outcomes, and stress- and autonomic-related biomarkers in adults with chronic insomnia. Chronic insomnia is a common sleep disorder characterized by persistent difficulties in initiating or maintaining sleep and is associated with impaired daytime functioning, reduced cognitive performance, and diminished quality of life. Non-pharmacological interventions may provide a safe alternative or complementary approach for individuals with chronic insomnia.
A total of 74 adults diagnosed with chronic insomnia by a neurologist and who have not used sleep medication during the previous four weeks will be enrolled. Participants will be randomly allocated to either a connective tissue massage group or a control group. The intervention group will receive 12 sessions of connective tissue massage over a four-week period, with three sessions per week, in addition to sleep hygiene education. The control group will receive sleep hygiene education alone.
Read more
Assessments will be performed at baseline and immediately after the four-week intervention period. The primary outcome will be the change in insomnia severity, assessed using the Insomnia Severity Index. Secondary outcomes will include objective sleep parameters recorded by actigraphy over five consecutive days, including total sleep time, sleep efficiency, sleep onset latency, and wake after sleep onset. Blood biomarkers associated with hypothalamic-pituitary-adrenal axis activity and autonomic regulation, including cortisol, DHEA-S, alpha-amylase, and oxytocin, will also be assessed. Subjective sleep quality and sleep hygiene will be evaluated using the Pittsburgh Sleep Quality Index and Sleep Hygiene Index, respectively. Adherence to sleep hygiene recommendations will additionally be assessed using sleep diaries.
The study aims to determine whether connective tissue massage combined with sleep hygiene education is more effective than sleep hygiene education alone in reducing insomnia severity and improving objective and subjective sleep outcomes and selected physiological biomarkers in adults with chronic insomnia.
- Conditions
- Chronic Insomnia
- Being tested
- Connective Tissue Massage, Sleep Hygiene Education
- Keywords
- Sleep, quality of sleep, Alpha Amylase, Sleep Disorders, Massage, Oxytocin, Physiotherapy, Cortisol, Physiotherapy and rehabilitation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective Tissue MassageProcedure or surgery
Connective tissue massage will be administered by a physiotherapist three times per week for four consecutive weeks, for a total of 12 sessions.
Sleep Hygiene EducationBehavioural
Standardized sleep hygiene education based on clinical guidelines will be provided verbally by a neurologist following the baseline assessment, and the same content will be provided to participants in written brochure format.
| Study group | Role | What they receive |
|---|---|---|
| Connective Tissue Massage + Sleep Hygiene Education | Experimental | Participants will receive standardized sleep hygiene education provided verbally by a neurologist and as a written brochure, in addition to 12 sessions of connective tissue massage delivered by a physiotherapist over four weeks, three sessions per week. Receives: Procedure: Connective Tissue Massage; Behavioral: Sleep Hygiene Education |
| Sleep Hygiene Education | Active comparator | Participants will receive standardized sleep hygiene education provided verbally by a neurologist and as a written brochure. No connective tissue massage will be provided during the four-week study period. Receives: Behavioral: Sleep Hygiene Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index Score
Change in insomnia severity will be assessed using the Insomnia Severity Index (ISI), a 7-item self-report questionnaire with total scores ranging from 0 to 28. Higher scores indicate greater insomnia severity, whereas lower scores indicate fewer insomnia symptoms. Scores are interpreted as follows: 0-7, no clinically significant insomnia; 8-14, subthreshold insomnia; 15-21, moderate clinical insomnia; and 22-28, severe clinical insomnia. The change in total score from baseline to the end of the intervention will be evaluated.
Measured: From baseline to 4 weeks
Secondary outcomes (12)
Change in Cortisol Level
Cortisol level will be assessed as a blood biomarker reflecting hypothalamic-pituitary-adrenal axis activity. The change from baseline to immediately after the 4-week intervention period will be evaluated.
Measured: From baseline to immediately after the 4-week intervention period
Change in DHEA-S Level
DHEA-S level will be assessed as a blood biomarker related to hypothalamic-pituitary-adrenal axis activity. The change from baseline to immediately after the 4-week intervention period will be evaluated.
Measured: From baseline to immediately after the 4-week intervention period
Change in Alpha-Amylase Level
Alpha-amylase level will be assessed as a blood biomarker related to autonomic regulation. The change from baseline to immediately after the 4-week intervention period will be evaluated.
Measured: From baseline to immediately after the 4-week intervention period
Change in Oxytocin Level
Oxytocin level will be assessed as a blood biomarker related to neuroendocrine and autonomic regulation. The change from baseline to immediately after the 4-week intervention period will be evaluated.
Measured: From baseline to immediately after the 4-week intervention period
Change in Total Sleep Time
Total sleep time will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in total sleep time will be evaluated.
Measured: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Sleep Efficiency
Sleep efficiency will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in sleep efficiency will be evaluated.
Measured: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Sleep Onset Latency
From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Measured: Sleep onset latency will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in sleep onset latency will be evaluated.
Change in Wake After Sleep Onset (WASO)
Wake after sleep onset (WASO) will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in WASO will be evaluated.
Measured: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Number of Nighttime Awakenings
The number of nighttime awakenings will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in the number of awakenings will be evaluated.
Measured: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Sleep Fragmentation Index
Sleep fragmentation index will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in sleep fragmentation index will be evaluated.
Measured: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Pittsburgh Sleep Quality Index Score
Subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The change in PSQI score from baseline to immediately after the 4-week intervention period will be evaluated.
Measured: From baseline to immediately after the 4-week intervention period
Change in Sleep Hygiene Index Score
Sleep hygiene behaviors will be assessed using the Sleep Hygiene Index (SHI). The change in SHI score from baseline to immediately after the 4-week intervention period will be evaluated.
Measured: From baseline to immediately after the 4-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770945
- Sponsor's protocol ID
- CTM-INSOMNIA-2026-01
- Other IDs
- 226S838
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding the sharing of individual participant data with other researchers has not yet been made. Any future data-sharing decisions will take into consideration participant confidentiality, applicable ethical requirements, and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Connective Tissue Massage in Patients With Chronic Insomnia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07770945
- Acronym / sponsor ID
- CTM-INSOMNIA-2026-01
- Conditions
- Chronic Insomnia
- Keywords
- Sleep, quality of sleep, Alpha Amylase, Sleep Disorders, Massage, Oxytocin, Physiotherapy, Cortisol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will investigate the effects of connective tissue massage on insomnia severity, objective and subjective sleep outcomes, and stress- and autonomic-related biomarkers in adults with chronic insomnia. Chronic insomnia is a common sleep disorder characterized by persistent difficulties in initiating or maintaining sleep and is associated with impaired daytime functioning, reduced cognitive performance, and diminished quality of life. Non-pharmacological interventions may provide a safe alternative or complementary approach for individuals with chronic insomnia.
A total of 74 adults diagnosed with chronic insomnia by a neurologist and who have not used sleep medication during the previous four weeks will be enrolled. Participants will be randomly allocated to either a connective tissue massage group or a control group. The intervention group will receive 12 sessions of connective tissue massage over a four-week period, with three sessions per week, in addition to sleep hygiene education. The control group will receive sleep hygiene education alone.
Assessments will be performed at baseline and immediately after the four-week intervention period. The primary outcome will be the change in insomnia severity, assessed using the Insomnia Severity Index. Secondary outcomes will include objective sleep parameters recorded by actigraphy over five consecutive days, including total sleep time, sleep efficiency, sleep onset latency, and wake after sleep onset. Blood biomarkers associated with hypothalamic-pituitary-adrenal axis activity and autonomic regulation, including cortisol, DHEA-S, alpha-amylase, and oxytocin, will also be assessed. Subjective sleep quality and sleep hygiene will be evaluated using the Pittsburgh Sleep Quality Index and Sleep Hygiene Index, respectively. Adherence to sleep hygiene recommendations will additionally be assessed using sleep diaries.
The study aims to determine whether connective tissue massage combined with sleep hygiene education is more effective than sleep hygiene education alone in reducing insomnia severity and improving objective and subjective sleep outcomes and selected physiological biomarkers in adults with chronic insomnia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective Tissue Massage + Sleep Hygiene Education | Experimental | Procedure: Connective Tissue Massage, Behavioral: Sleep Hygiene EducationParticipants will receive standardized sleep hygiene education provided verbally by a neurologist and as a written brochure, in addition to 12 sessions of connective tissue massage delivered by a physiotherapist over four weeks, three sessions per week. |
| Sleep Hygiene Education | Active comparator | Behavioral: Sleep Hygiene EducationParticipants will receive standardized sleep hygiene education provided verbally by a neurologist and as a written brochure. No connective tissue massage will be provided during the four-week study period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 to 65 years, of either sex.
- Diagnosis of chronic insomnia disorder according to the International -Classification of Sleep Disorders, Third Edition, Turkish version (ICSD-3-TR), established by a neurologist.
- Difficulty initiating or maintaining sleep occurring at least three nights per week for at least three months, consistent with ICSD-3-TR diagnostic criteria.
- No use of pharmacological agents for insomnia during the previous four weeks, including benzodiazepines, non-benzodiazepine hypnotics, melatonin and melatonin receptor agonists, sedating antidepressants, and anxiolytics.
- Insomnia Severity Index score of ≥15, indicating moderate to severe insomnia. Ability to read and write.
Key exclusion criteria (6 listed)
- History of shift work during the previous month or lifestyle changes that may disrupt circadian rhythm.
- Presence of obstructive sleep apnea syndrome, circadian rhythm sleep-wake disorders, or other primary sleep disorders.
- History of any neurological diagnosis, such as epilepsy or Parkinson's disease, or psychiatric diagnosis, such as depression or bipolar disorder.
- Presence of an open wound, infection, dermatitis, or other dermatological condition impairing skin integrity in the area where connective tissue massage will be applied.
- Regular use of medications that may affect sleep, including antidepressants, beta-blockers, or corticosteroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connective Tissue MassageConnective tissue massage will be administered by a physiotherapist three times per week for four consecutive weeks, for a total of 12 sessions. | Procedure or surgery | Connective Tissue Massage + Sleep Hygiene Education |
| Sleep Hygiene EducationStandardized sleep hygiene education based on clinical guidelines will be provided verbally by a neurologist following the baseline assessment, and the same content will be provided to participants in written brochure format. | Behavioural | Connective Tissue Massage + Sleep Hygiene Education, Sleep Hygiene Education |
Primary outcome
Change in Insomnia Severity Index Score
Time frame: From baseline to 4 weeks
Change in insomnia severity will be assessed using the Insomnia Severity Index (ISI), a 7-item self-report questionnaire with total scores ranging from 0 to 28. Higher scores indicate greater insomnia severity, whereas lower scores indicate fewer insomnia symptoms. Scores are interpreted as follows: 0-7, no clinically significant insomnia; 8-14, subthreshold insomnia; 15-21, moderate clinical insomnia; and 22-28, severe clinical insomnia. The change in total score from baseline to the end of the intervention will be evaluated.
12 secondary outcomes
Change in Cortisol Level
Time frame: From baseline to immediately after the 4-week intervention period
Change in DHEA-S Level
Time frame: From baseline to immediately after the 4-week intervention period
Change in Alpha-Amylase Level
Time frame: From baseline to immediately after the 4-week intervention period
Change in Oxytocin Level
Time frame: From baseline to immediately after the 4-week intervention period
Change in Total Sleep Time
Time frame: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Sleep Efficiency
Time frame: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Sleep Onset Latency
Time frame: Sleep onset latency will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in sleep onset latency will be evaluated.
Change in Wake After Sleep Onset (WASO)
Time frame: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Number of Nighttime Awakenings
Time frame: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Sleep Fragmentation Index
Time frame: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Pittsburgh Sleep Quality Index Score
Time frame: From baseline to immediately after the 4-week intervention period
Change in Sleep Hygiene Index Score
Time frame: From baseline to immediately after the 4-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided. A decision regarding the sharing of individual participant data with other researchers has not yet been made. Any future data-sharing decisions will take into consideration participant confidentiality, applicable ethical requirements, and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective Tissue Massage and Sleep Hygiene Education in people with Chronic Insomnia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nergis Yılmaz (+90 5318549782, nergis-yilmaz39@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index Score (time frame: From baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.